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《印度尼西亚早产儿长期结局队列研究(CIPTO):方案》

The Cohort of Indonesian Preterm Infants for Long-term Outcomes (CIPTO) study: a protocol.

机构信息

Division of Perinatology, Department of Child Health, Faculty of Medicine Universitas Indonesia, Cipto Mangunkusumo General Hospital, Jakarta, Indonesia.

Division of Growth and Development Social Pediatrics, Department of Child Health, Faculty of Medicine Universitas Indonesia, Cipto Mangunkusumo General Hospital, Jakarta, Indonesia.

出版信息

BMC Pediatr. 2023 Oct 19;23(1):518. doi: 10.1186/s12887-023-04263-z.

Abstract

BACKGROUND

Indonesia has high numbers of preterm birth, i.e., around 600,000 preterm births annually. It imposes a significant burden on the Indonesia's healthcare system. Indonesia therefore requires its own evidence-based reference to manage premature neonates and ex-preterm infants who subsequently survived. No long-term study on preterm infants in Indonesia has been conducted, therefore we aim to evaluate growth and development on ex-preterm infants until the pre-pubertal stage.

METHODS

We at the Cipto Mangunkusumo General Hospital (CMGH) designed a prospective cohort study of preterm infants, i.e., the Cohort of Indonesian Preterm Infants for Long-term Outcomes (CIPTO) study. At least 500 subjects will be recruited with an estimation of two-year recruitment (i.e., the recruitment phase will be completed before 2024). The CIPTO study will observe long-term outcomes of ex-preterm infants, primarily on growth and developmental milestones until 8 years old. Aims of this study are to determine the ex-preterm outcomes and to generate an evidence-based reference of preterm care for ensuring optimum outcomes. The pre-specified long-term outcomes in this study are survival rates, growth outcomes, neurodevelopmental outcomes, feeding behavior, as well as hearing and vision impairments. Growth and neurodevelopmental outcomes will be assessed at 0, 2, 4, 6, 9, 12, 15, 18 and 24 months of corrected age as well as at 3, 4, 5, 6, 7 and 8 years old.

DISCUSSION

The CIPTO study is the first prospective cohort in Indonesia focusing on preterm infants born at the CMGH. With a follow up until 8 years old, this study may provide useful insights to generate an evidence-based, Indonesia's health care reference in managing premature infants and ensuring the optimum outcomes of ex-preterm infants.

摘要

背景

印度尼西亚的早产儿数量很高,每年约有 60 万例早产儿。这给印度尼西亚的医疗保健系统带来了巨大的负担。因此,印度尼西亚需要自己的基于证据的参考标准来管理早产儿和随后幸存的早产儿。印度尼西亚尚未对早产儿进行长期研究,因此我们旨在评估早产儿直到青春期前阶段的生长和发育情况。

方法

我们在 Cipto Mangunkusumo 综合医院(CMGH)设计了一项早产儿前瞻性队列研究,即印度尼西亚早产儿长期结局队列研究(CIPTO)。预计将招募至少 500 名受试者,估计需要两年的招募时间(即,招募阶段将在 2024 年前完成)。CIPTO 研究将观察早产儿的长期结局,主要是生长和发育里程碑,直到 8 岁。本研究的目的是确定早产儿的结局,并为早产儿护理提供循证参考,以确保最佳结局。本研究中预先指定的长期结局是生存率、生长结局、神经发育结局、喂养行为以及听力和视力障碍。生长和神经发育结局将在校正年龄 0、2、4、6、9、12、15、18 和 24 个月以及 3、4、5、6、7 和 8 岁时进行评估。

讨论

CIPTO 研究是印度尼西亚首次针对在 CGMH 出生的早产儿进行的前瞻性队列研究。随访至 8 岁,本研究可能提供有用的见解,以生成印度尼西亚医疗保健的循证参考标准,用于管理早产儿并确保早产儿的最佳结局。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a15a/10585843/84e217eb33cb/12887_2023_4263_Fig1_HTML.jpg

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